Batch BT-020592
Hemovance • NWK • L043 • completed
About this view
This batch detail page ties execution evidence, material genealogy, equipment fitness, in-process controls, and quality events into one release-focused view. Users can trace each unit operation against timestamps and investigate linked exceptions without leaving context. The panelized layout supports QA review by exception while preserving full evidence access. Next actions include closing residual issues and completing disposition-ready evidence checks.
Planned
2026-11-21 → 2026-12-04
Actual
2026-09-16 → 2025-09-02
Exceptions
7
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011776 | Magnesium Stearate Variant 9 | quarantine | Open workbench |
| LOT-011777 | Croscarmellose Sodium Variant 9 | hold | Open workbench |
| LOT-011778 | Povidone K30 Variant 9 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01336 Hardness Tester #337 | operational | 2026-03-12 | qualified |
| AST-01337 Friability Tester #338 | operational | 2025-07-15 | qualified |
| AST-01338 Particle Size Analyzer #339 | operational | 2025-08-08 | requalification-due |
| AST-01339 Microscope #340 | in-calibration | 2026-06-15 | not-qualified |
| AST-01340 Laminar Flow Cabinet #341 | in-maintenance | 2026-06-10 | qualified |
| AST-01341 Isolator #342 | out-of-service | 2025-05-08 | qualified |
| AST-01342 WFI Still #343 | cleaning-required | 2026-01-13 | qualified |
| AST-01343 RO System #344 | operational | 2025-09-10 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Out of Specification | major | under-review | Not linked |
| Out of Specification | major | under-review | Not linked |
| Out of Specification | major | under-review | Not linked |
| Out of Specification | major | under-review | Not linked |
| Out of Specification | major | under-review | Not linked |
| Out of Specification | major | under-review | Not linked |
QA Review Checklist and Signatures
- Step execution completeness verified with signed evidence.
- All high-severity exceptions dispositioned or justified.
- QC release tests reviewed and OOS investigations closed or dispositioned.
- Final release signatory validated with segregation-of-duties check.
No release readiness record found.